The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Link Blood Glucose Data Management System.
Device ID | K952279 |
510k Number | K952279 |
Device Name: | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM |
Classification | Glucose Oxidase, Glucose |
Applicant | MEDISENSE, INC. 266 SECOND AVE. Waltham, MA 02154 |
Contact | Michael Halpin |
Correspondent | Michael Halpin MEDISENSE, INC. 266 SECOND AVE. Waltham, MA 02154 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-11 |
Decision Date | 1995-06-14 |